Health
Children with autism may see speech improvements with off-label prescription drug
An off-label prescription drug has been shown to help some non-verbal children with autism discover the ability to speak.
The drug, leucovorin, is a prescription vitamin that functions similarly to folic acid, helping to restore folate levels in patients who may have difficulty absorbing or using it, according to Katy Dubinsky, a New York pharmacist and the CEO and co-founder of Vitalize, a private supplement company.
“Leucovorin is FDA-approved to reduce the toxic effects of high-dose methotrexate in cancer treatment and to prevent or treat certain types of anemia caused by folate deficiency,” Dubinsky told Fox News Digital.
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While leucovorin isn’t prescribed for the treatment of autism, some families have found that its off-label use has led to significant improvements in autistic children’s communication skills, experts say.
Richard E. Frye, M.D., PhD, a behavioral child neurologist in Arizona, has studied the drug in his research of experimental treatments for children with autism spectrum disorder.
An off-label prescription drug has been shown to help some non-verbal children with autism discover the ability to speak. (iStock)
“Leucovorin is a special form of vitamin B9 that is water-soluble and does not build up in your body,” he told Fox News Digital.
“Folates have been found to be safe long-term for many years and that is why we supplement our food with folate.”
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The main benefit of leucovorin for children with autism is improvement in language, Frye said, but other advantages may include enhanced social function, reduced repetitive behaviors and stronger attention skills.
“Our goal is to get leucovorin approved by the FDA for autism so it can be widely prescribed to children as one of the first treatments once they are diagnosed.”
“We do find that leucovorin helps a substantial number of children with autism,” he said. “Language is one of the most obvious things, so that is what we measured in our clinical trial.”
Dr. Marc Siegel, clinical professor of medicine at NYU Langone Health and Fox News’ senior medical analyst, also spoke to Fox News Digital about why the drug may have this positive impact.
While leucovorin isn’t prescribed for autism treatment, some families have found that its off-label use has led to significant improvements in the communication skills of children with autism. (iStock)
“Central folate deficiency is a lack of folate in the brain, which can interfere with neurological function,” he said. “A high percentage of children with autism spectrum disorder have been found to have antibodies against folic receptor alpha in the brain.”
Leucovorin is converted to folate in the brain by a different pathway, Siegel said.
“Small studies are showing that it improves neurological function and communication skills in kids with ASD, but larger studies need to be done.”
Experts urge caution
The fact that leucovorin has already been used long-term helps to reduce the associated risk, according to doctors.
“One of the advantages of using leucovorin is that it has been used for decades to protect the body from the effects of chemotherapy, so we know what dose to use and any side effects it may produce,” Frye told Fox News Digital.
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However, some children do become “extremely hyperactive,” do not respond to leucovorin and end up needing alternative treatments, the doctor noted.
It’s important for families to work with a medical professional when exploring the use of leucovorin for autism, he advised.
The drug leucovorin is a prescription vitamin that functions similarly to folic acid, helping to restore folate levels in patients who may have difficulty absorbing or using it, according to a pharmacist. (iStock)
“Leucovorin is given at much higher doses than regular vitamins, so it’s very important to work with a doctor knowledgeable in how to prescribe it,” Frye said.
“It is important to test the patient for abnormalities in the folate pathway, such as the folate receptor autoantibody, so we know that they are a candidate for this medication.”
While leucovorin is available in the pharmacy, Frye noted that some children need a compounded form because they are sensitive to some of the additives in commercial products.
“Our goal is to get leucovorin approved by the FDA for autism so it can be widely prescribed to children as one of the first treatments once they are diagnosed,” he said.
Frye pointed out that there is “no magic bullet” for autism, with many children benefiting from a combination of multiple treatments. (iStock)
Dubinsky agreed that physicians may prescribe the “widely used and well-tolerated drug” for autism treatment based on their “clinical judgment and emerging evidence,” but she also stressed the importance of clinical trials.
“While doctors can prescribe leucovorin now, FDA approval would provide stronger medical backing, making it a recognized treatment rather than just an off-label option,” she told Fox News Digital.
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“This could lead to insurance coverage, standardized dosing guidelines and broader acceptance in the medical community.”
Siegel added that leucovorin is a “safe drug” and should be considered for large-scale use based on the findings of recent research.
‘No magic bullet’
Frye pointed out that there is “no magic bullet” for autism, with many children benefiting from a combination of multiple treatments.
“It is unlikely that leucovorin will be used alone — it must be used with behavioral and speech therapy,” he said. “We believe that leucovorin can improve outcomes for these therapies.”
“There is little evidence to suggest that the benefits observed in this individual case can be generalized to the broader autistic community.”
Andy Shih, PhD, chief science officer of Autism Speaks in New York, noted that every child’s experience with autism is unique.
“There is little evidence to suggest that the benefits observed in this individual case can be generalized to the broader autistic community,” he told Fox News Digital.
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“While some small studies have explored leucovorin as a potential treatment for people with autism, larger controlled clinical trials are needed to determine its efficacy and safety. We urge families to consult with their doctors before considering off-label treatments.”
Dubinsky added that if larger studies confirm leucovorin’s effectiveness, it could become a more accessible treatment for children with autism who may benefit from it.
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Health
Common eating habit may trigger premature immune system aging, study finds
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Eating too much salt has long been linked to high blood pressure, but new research suggests it could trick the immune system into prematurely aging the blood vessels.
A preclinical study recently published in the Journal of the American Heart Association has identified a biological chain reaction that links a salty diet to cardiovascular decay.
Scientists at the University of South Alabama observed that mice on a high-salt diet experienced rapid deterioration in their blood vessel function.
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After just four weeks of high sodium intake, the small arteries responsible for regulating blood flow lost their ability to relax, according to a press release.
The team found that the cells lining these vessels had entered a state of cellular senescence, a form of premature cellular aging in which cells stop dividing and release a mix of inflammatory signals that can damage surrounding tissue.
Excess salt has long been linked to high blood pressure, but a new study goes deeper into its effects on the cardiovascular system. (iStock)
The researchers tried to replicate this damage by exposing blood vessel cells directly to salt in a laboratory dish, but the cells showed no harmful effects.
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This suggests that salt isn’t directly causing damage to the vascular lining but that the real culprit may be the body’s own defense mechanism, the researchers noted.
Excess salt may trigger the immune system to release a molecule called interleukin-16 (IL-16), which acts as a messenger that instructs blood vessel cells to grow old before their time, according to the study.
Excess salt may trigger the immune system to release a molecule called interleukin-16, which acts as a messenger that instructs blood vessel cells to grow old before their time, according to the study. (iStock)
Once these cells age, they fail to produce nitric oxide, the essential gas that tells arteries to dilate and stay flexible.
To test whether this process could be reversed, the team turned to a class of experimental drugs known as senolytics.
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Using a cancer medication called navitoclax, which selectively clears out aged and dysfunctional cells, the researchers were able to restore nearly normal blood vessel function in the salt-fed mice, the release stated.
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By removing the decaying cells created by the high-salt diet, the drug allowed the remaining healthy tissue to maintain its elasticity and respond correctly to blood flow demands.
Excess salt may trigger the immune system into stopping the cells from dividing, the study suggests. (iStock)
The study did have some limitations. The transition from mouse models to human treatment remains a significant hurdle, the team cautioned.
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Senolytic drugs like navitoclax are still being studied for safety, and the team emphasized that previous trials have shown mixed results regarding their impact on artery plaque.
Additionally, the researchers have not yet confirmed whether the same IL-16 pathway is the primary driver of vascular aging in humans.
Health
Healthy diets spark lung cancer risk in non-smokers as pesticides loom
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Eating a diet high in fruits and vegetables was found to have a surprising link to lung cancer among younger non-smokers, early research suggests.
The observational study, led by Jorge Nieva, M.D., of the USC Norris Comprehensive Cancer Center at Keck Medicine, was presented this month at the American Association for Cancer Research (AACR) annual meeting in San Diego. It has not yet been peer-reviewed.
Researchers looked at dietary, smoking and demographic data for 187 patients who were diagnosed with lung cancer at age 50 or younger.
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They found that among non-smokers, there was a link between healthier-than-average diets – rich in fruits, vegetables and whole grains – and the chance of lung cancer development.
Young lung cancer patients ate more servings of dark green vegetables, legumes and whole grains compared to the average U.S. adult, the researchers found.
Eating a diet high in fruits and vegetables was found to have a surprising link to lung cancer among younger non-smokers, early research suggests. (iStock)
The researchers hypothesized that pesticides applied to conventionally grown produce could be a possible factor in the disease association.
“Commercially produced (non-organic) fruits, vegetables and whole grains are more likely to be associated with a higher residue of pesticides than dairy, meat and many processed foods,” according to Nieva. He also noted that agricultural workers exposed to pesticides tend to have higher rates of lung cancer.
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“There is a large subset of lung cancer patients whose disease is not caused by smoking,” Nieva told Fox News Digital.
The disease is becoming more common in non-smokers 50 and younger, especially women – despite the fact that smoking rates have been falling for decades, the researcher noted.
The researchers hypothesized that pesticides applied to conventionally grown produce could be a possible factor in the disease association. (iStock)
“These patients tend to have eaten much healthier diets before their diagnosis than the average American,” he went on. “We need to support research into understanding why Americans – and women in particular – who no longer smoke very much are still having lung cancer,” he said.
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The study did have some limitations, Nieva acknowledged, primarily that it relied on survey data and was limited by the participants’ memories of their food intake.
“Also, the survey participants were self-selected, and this could have biased the findings,” he told Fox News Digital.
“There is a large subset of lung cancer patients whose disease is not caused by smoking.”
The researchers did not test specific foods for pesticides, relying instead on average pesticide levels for certain types of food. Looking ahead, they plan to test patients’ blood and urine samples to directly measure pesticide levels, Nieva said.
Although the study shows only an association and does not prove that pesticides caused lung cancer, Nieva recommends that people wash their produce before eating and choose organic foods whenever possible.
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“This work represents a critical step toward identifying modifiable environmental factors that may contribute to lung cancer in young adults,” said Nieva. “Our hope is that these insights can guide both public health recommendations and future investigation into lung cancer prevention.”
“It is possible that the increased lung cancer risk could be due to pesticide exposure in whole farmed foods, but is by no means certain,” a doctor said. (AP Photo/Charlie Neibergall)
Dr. Marc Siegel, Fox News senior medical analyst, said the study is “interesting,” but that it “raises far more questions than it answers.”
“It is a small study (around 150) and observational, so no proof,” the doctor, who was not involved in the research, told Fox News Digital.
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“It is possible that the increased lung cancer risk could be due to pesticide exposure in whole farmed foods, but it is by no means certain,” Siegel went on. “How much exposure is needed? How much of it gets into food and in which areas? This requires much further study.”
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Kayla Nichols, communications director for Pesticide Action & Agroecology Network, a distributed global network, said the organization agrees with the study’s conclusion that more research should be done on the rise in lung cancer, particularly in individuals eating diets higher in produce and fiber.
“There is a large subset of lung cancer patients whose disease is not caused by smoking,” the researcher told Fox News Digital. (iStock)
“There is a bounty of existing research that already links pesticide exposure to increased risk of multiple types of cancers,” Nichols, who was also not involved in the study, told Fox News Digital. She called for more research on chronic, low-level exposures to pesticides, as well as more effective policies to protect the public from pesticide residues on food.
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The study was supported by the National Institutes of Health and the National Cancer Institute, as well as industry partners including AstraZeneca and Genentech, among others.
Fox News Digital reached out to several pesticide companies and trade groups for comment.
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